Health TrialsbyHealthPanel

An Interactive Education Program to Reduce High Risk Behavior in Adolescents Ph II (iTRAC HERO)

ConditionsRisky Sexual BehaviorEmotion RegulationAdolescent Behavior
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-14
SponsorKlein Buendel, Inc.

About this trial

Using the efficacious iTRAC intervention to enhance emotion regulation competencies as a foundation, this study will create and test iTRAC-HERO to teach emotion regulation skills in the context of sexual health education.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Attending 7th grade

Between 12 and 14 years old

Parent/guardian speaks English or Spanish

Attending participating school

Disqualifiers

Unable to read at a 4th grade level

Have a sibling who has participated in the study

Have a development disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • iTRAC-HERO

    Behavioral

    iTRAC-HERO will consist of eight, approximately 45-minute, "gamified" digital modules of 4-6 activities (games, videos, etc.). No instruction is needed to use the program. Content will use gender- and sexuality-inclusive language and avoid heteronormative descriptions of risk. This content will include strategies for (and practice with) recognizing and managing emotions, particularly in relation to sexual health situations, to enhance the likelihood that the emotion regulation and sexual health education provided can be applied to experiences that are emotionally arousing and lead to risk.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Waitlist ControlNo intervention 0 interventions
Group B: iTRAC-HEROExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Sexual Self-Efficacy (SSE) from baseline to 6 months.

The Sexual Self-Efficacy Scale (12 items) will measure self-efficacy for safer sexual activity as a main outcome which will indicate iTRAC-HERO's efficacy and ability to promote healthier sexual behaviors with the full sample (not just those who are sexually active).

Time frame
Baseline, 1 month post-intervention, 6 month follow up
2

Change in Self Efficacy for HIV Prevention from baseline to 6 month.

The Self-Efficacy for HIV Prevention Scale (12 items) assesses a range of behaviors related to prevention of HIV, other STIs, or unintended pregnancy, including refusing sexual behaviors, discussing sexual histories with partners, buying condoms, taking free condoms, carrying condoms, and asking a partner to use a condom.

Time frame
Baseline, 1 month post-intervention, 6 month follow up

Secondary outcomes

1

Change in Sexual Risk Cognition from baseline to 6 months

The Sexuality Questionnaire for Adolescents (34 items) is a multiple choice test to assess sexual health knowledge and has been shown to be sensitive to intervention impact.

Time frame
Baseline, 1 month post-intervention, 6 month follow up
2

Change in attitudes towards abstinence from baseline to 6 months

The Abstinence Attitudes questionnaire assesses agreement with values related to abstinence (α= .86).

Time frame
Baseline, 1 month post-intervention, 6 month follow up
3

Change in frequency of sexual and substance use behaviors from baseline to 6 months

The Adolescent Risk Behavior Assessment (ARBA) will assess sexual behavior, including behaviors relevant to this developmental period.

Time frame
Baseline, 1 month post-intervention, 6 month follow up
4

Change in adolescent substance use behaviors from baseline to 6 months

Youth Risk Behavior Surveillance System items will be used to assess tobacco/vape use, violence (e.g., fighting), and substance use behaviors.

Time frame
Baseline, 1 month post-intervention, 6 month follow up

Other outcomes

1

Change in Emotion Regulation Skills from baseline to 6 months

The Difficulties in Emotion Regulation Scale (36 items) uses six subscales (e.g., lack of emotional awareness, limited access to ER strategies; all α \> .80) to assess perceptions of skill in ER based on Linehan's theoretical work.

Time frame
Baseline, 1 month post-intervention, 6 month follow up
2

Change in frequency of dificulties with emotion regulation from baseline to 6 months

The Affect Dysregulation Scale (6 items) assesses the frequency of difficulties with ER (α= .72), and is shown to be related to adolescent risk behaviors.

Time frame
Baseline, 1 month post-intervention, 6 month follow up
3

Change in usage of emotion regulation behaviors taught in iTRAC-HERO from baseline to 6 months

The Emotion Regulation Behaviors Scale- Revised measures use of the specific emotion regulation strategies taught in iTRAC (α= .73).

Time frame
Baseline, 1 month post-intervention, 6 month follow up
4

Change in perceptions of one's ability to manage negative emotions from baseline to 6 months

The Emotional Self-Efficacy Subscale of the Self-Efficacy Questionnaire for Children assesses perception of one's ability to cope with negative emotions (α= .83).

Time frame
Baseline, 1 month post-intervention, 6 month follow up

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Klein Buendel, Inc.

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Rhode Island Hospital

Collaborator

University of Oregon

Collaborator

Source ClinicalTrials.gov
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